Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name needle, fistula
510(k) Number K992653
Device Name SHELLY PROTECTED AV FISTULA NEEDLE
Applicant
DIASOL, INC.
13212 RAYMER ST.
NORTH HOLLYWOOD,  CA  91605
Applicant Contact MONICA ABELES
Correspondent
DIASOL, INC.
13212 RAYMER ST.
NORTH HOLLYWOOD,  CA  91605
Correspondent Contact MONICA ABELES
Regulation Number876.5540
Classification Product Code
FIE  
Date Received08/06/1999
Decision Date 10/27/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-